In September 2010, Merck (known as MSD outside the United States and Canada) and Cardiome announced that intravenous (IV) formulation of BRINAVESS™ (vernakalant) was granted marketing approval in the European Union (EU), Iceland and Norway for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults for non-surgery patients with atrial fibrillation of seven days duration or less and for post-cardiac surgery patients with atrial fibrillation of three days duration or less. BRINAVESS™ has been commercially launched by Merck in a number of countries, and further product launches are planned for the remaining countries for which marketing approval has been obtained worldwide.
BRINAVESS™ acts preferentially in the atria and is the first product in a new class of pharmacologic agents for cardioversion of AF to launch worldwide. To date, over 10,000 AF patients have had their recent onset AF episodes safely treated with BRINAVESS™.
The US FDA placed vernakalant IV on clinical hold during the Phase III ACT V trial in October 2010. Cardiome plans to work with the FDA to lift the hold and resume clinical development for the US market.
Sentiment: Strong Buy
If dr.hunter did not think this drug is coming soon then why he will buy 2 million ? Why he will hold a $ million ? Vernakalant iv is not in phase 1 or 2, it is in last stage of phase 3.
merck is having many drugs pending with fda so vernakalant was not on the top of the list but now it is the only drug on cardiome list. Start removing the fda hold can not be larter than march 31 when cardiom complete transfer.fda hold was before the approval in the european union and now that will help to speed up fda approval
Sentiment: Strong Buy
If safety data from 10,000 patients is not good enough to lift the clinical hold in the US I don't know what is. I believe Merck had changed its strategic priorities and paid lip service to manage the IV and ended up giving up oral. Now that Merck is out of the picture and Cardiome depends on one drug to sink or swim new management will do everything humanly possible get it to succeed. CEO's purchase of 2 million shares shows their conviction and willingness to work hard. Not to mention Dr. Hunter has impressive credentials and turned other biotech start-ups around with great success. Previous management was one of the worst in the industry and responsible for the share price crash.Now, the story is altogether different. If you bother to check the records from few years ago this stock traded over $11-13 per share even when the oral was not in the picture.
Sentiment: Strong Sell